- Subjects with brain metastasis are excluded, unless they are free of neurologic
symptoms related to metastatic brain lesions and do not receive systemic
corticosteroid therapy for the purpose of reducing intracranial inflammation in the
10 days prior to beginning retreatment with Ipilimumab

- Any intervening anticancer therapy between last dose of Ipilimumab induction and
Ipilimumab retreatment on study

Type of Study:

Study Design:

Outcome Measure:

Survival rate

Outcome Description:

The survival rate at 18 months is defined as the proportion of subjects still alive at 18 months or more from randomization divided by the total number of subjects randomized. Vital status will be assessed at each study visit. Analysis of overall survival rate will be done at 18 months from LPFV

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